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Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Category : Deviations

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Mar 14, 2025

Category : Discussions

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Mar 14, 2025

Category : Uncategorized
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Feb 10, 2025

Natco Pharma USFDA 483:Cleaning deficiencies, Data Integrity

Feb 05, 2025

Category : Guideline

Healthy Life Style

Mar 11, 2025

Life Style

Mar 06, 2025

USFDA 483 /Dr.Reddys (DRL) / October 2023 / Cleaning deficiencies,...

Feb 27, 2025

Category : Import Alerts

Healthy Life Style

Mar 11, 2025

Test 26 feb 123456

Feb 26, 2025

Category : Medicine

Healthy Life Style

Mar 11, 2025

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Feb 26, 2025

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Feb 13, 2025

Medicine (CalmiRest)

Sep 18, 2024

Category : Quality Insights
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Mar 11, 2025

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Mar 06, 2025

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Feb 27, 2025

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Feb 26, 2025

Quality Insight Test Data

Nov 01, 2024

The Quality Insight Test Post

Nov 01, 2024

Medicine (CalmiRest)

Sep 18, 2024

Category : Qvents
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Life Style

Mar 06, 2025

Feb 27 test

Feb 27, 2025

Test 26 feb 123456

Feb 26, 2025

USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies...

Oct 30, 2023

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps...

Oct 30, 2023

Potential cross contamination with ßlactam (beta lactam) drug substance –...

Oct 09, 2023

Warning letter / Centaur / July 2023 / Cleaning deficiencies,...

Sep 19, 2023

Warning letter / Medgel / July 2023 / Failure to...

Aug 23, 2023

Warning letter / Medgel / July 2023 /Lapses in Quality...

Aug 23, 2023

Warning letter / Medgel / July 2023 / Inadequate Investigation...

Aug 23, 2023

Warning letter / Centaur / July 2023 / Failure of...

Aug 07, 2023

USFDA 483 / IPCA / June 2023 /Inadequate OOS investigations,...

Aug 02, 2023

USFDA 483 / Intas / May 2023 /Failure to review...

Jul 24, 2023

USFDA 483 / Intas / May 2023 /Manipulation of Visual...

Jul 24, 2023

USFDA 483 / IPCA / June 2023 /Failure of Quality...

Jul 07, 2023

USFDA 483 / IPCA / June 2023 /Failure in Investigation...

Jul 06, 2023

Warning letter (2019) / Cadila, India / Critical deviation Residues in...

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 / UCB, Belgium / FEI 3003909356/ USFDA Investigators:...

Jun 03, 2023

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/...

Jun 01, 2023

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/...

May 29, 2023

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/...

May 27, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG),...

May 10, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 08, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 03, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 01, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 28, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 28, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 22, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 21, 2023

USFDA 483 / Cipla,  Pithampur, India / FEI 3008581988/ Inspection...

Apr 19, 2023

USFDA 483 / Intas, Matoda, India / FEI 3004011473 /...

Apr 18, 2023

Recall / Event ID: 91441/ Recall Number: D-0162-2023 / Macleods/...

Apr 18, 2023

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS...

Apr 18, 2023

Recall / Accord Healthcare /Daptomycin for Injection 500 mg/vial and...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS...

Apr 18, 2023

Warning letter / Lupin / MARCS-CMS 633703 / 320-22-25 /...

Apr 17, 2023

USFDA 483 / Jubilant Roorkee / FEI 3006895982 /1 Aug...

Apr 17, 2023

USFDA 483 / Jubilant Roorkee / 3006895982 /1 Aug 2022...

Apr 17, 2023

USFDA 483 / Jubilant Roorkee / 3006895982 /1 Aug 2022...

Apr 17, 2023

Recall / Event ID:90634 / Recall Number: D-1330-2022 / Strides...

Apr 17, 2023

Warning letter / Mylan / MARCS-CMS 607508 / 320-20-44 /...

Apr 17, 2023

Warning letter /Mylan / MARCS-CMS 607508 / 320-20-44 / Aug...

Apr 14, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 11, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 11, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 11, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 10, 2023

Category : 483s
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Feb 27 test

Feb 27, 2025

Test 26 feb 123456

Feb 26, 2025

USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies...

Oct 30, 2023

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps...

Oct 30, 2023

USFDA 483 / IPCA / June 2023 /Inadequate OOS investigations,...

Aug 02, 2023

USFDA 483 / Intas / May 2023 /Failure to review...

Jul 24, 2023

USFDA 483 / Intas / May 2023 /Manipulation of Visual...

Jul 24, 2023

USFDA 483 / IPCA / June 2023 /Failure of Quality...

Jul 07, 2023

USFDA 483 / IPCA / June 2023 /Failure in Investigation...

Jul 06, 2023

Warning letter (2019) / Cadila, India / Critical deviation Residues in...

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 / UCB, Belgium / FEI 3003909356/ USFDA Investigators:...

Jun 03, 2023

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/...

Jun 01, 2023

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/...

May 29, 2023

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/...

May 27, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG),...

May 10, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 08, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 03, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 01, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 28, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 28, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 22, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 21, 2023

USFDA 483 / Cipla,  Pithampur, India / FEI 3008581988/ Inspection...

Apr 19, 2023

USFDA 483 / Intas, Matoda, India / FEI 3004011473 /...

Apr 18, 2023

USFDA 483 / Jubilant Roorkee / FEI 3006895982 /1 Aug...

Apr 17, 2023

USFDA 483 / Jubilant Roorkee / 3006895982 /1 Aug 2022...

Apr 17, 2023

USFDA 483 / Jubilant Roorkee / 3006895982 /1 Aug 2022...

Apr 17, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 11, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 11, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 11, 2023

USFDA 483 / Torrent, Indrad, India / FEI 3005029956 /...

Apr 10, 2023

Category : Audit-reports

Feb 27 test

Feb 27, 2025

Category : OOS

Feb 27 test

Feb 27, 2025

Category : Recalls
View All

Test 26 feb 123456

Feb 26, 2025

Potential cross contamination with ßlactam (beta lactam) drug substance –...

Oct 09, 2023

Recall / Event ID: 91441/ Recall Number: D-0162-2023 / Macleods/...

Apr 18, 2023

Recall / Accord Healthcare /Daptomycin for Injection 500 mg/vial and...

Apr 18, 2023

Recall / Event ID:90634 / Recall Number: D-1330-2022 / Strides...

Apr 17, 2023

Category : Warning Letters
View All

Test 26 feb 123456

Feb 26, 2025

Warning letter / Centaur / July 2023 / Cleaning deficiencies,...

Sep 19, 2023

Warning letter / Medgel / July 2023 / Failure to...

Aug 23, 2023

Warning letter / Medgel / July 2023 /Lapses in Quality...

Aug 23, 2023

Warning letter / Medgel / July 2023 / Inadequate Investigation...

Aug 23, 2023

Warning letter / Centaur / July 2023 / Failure of...

Aug 07, 2023

Warning letter (2019) / Cadila, India / Critical deviation Residues in...

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG),...

May 10, 2023

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS...

Apr 18, 2023

Warning letter / Lupin / MARCS-CMS 633703 / 320-22-25 /...

Apr 17, 2023

Warning letter / Mylan / MARCS-CMS 607508 / 320-20-44 /...

Apr 17, 2023

Warning letter /Mylan / MARCS-CMS 607508 / 320-20-44 / Aug...

Apr 14, 2023

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Mar 06, 2025

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Mar 06, 2025

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Feb 27, 2025

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Feb 27, 2025