Apothecon Pharmaceuticals Private Limited
Form 483 issued January 27, 2023 · Vadodara, India
- Inspection
- Jan 17 – Jan 27, 2023
- Investigators
- Alan P. Kurtzberg· Santos E. Camara
- Observations
- 6
- Pages
- 4
- FEI number
- 3008405956
In short: On January 27, 2023, FDA issued a Form 483 with 6 observations to Apothecon Pharmaceuticals Private Limited in Vadodara, Gujarat (FEI 3008405956) after an inspection that ran Jan 17 – Jan 27, 2023. The investigators were Alan P. Kurtzberg and Santos E. Camara. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to report all raw data results collected and adequately investigate out specification…
- 02
The accuracy and sensitivity of test methods…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmApothecon Pharmaceuticals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apothecon Pharmaceuticals Private Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Apothecon Pharmaceuticals Private Limited?
Alan P. Kurtzberg and Santos E. Camara are named on this Form 483, for the inspection of Jan 17 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was Apothecon Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jan 17 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for Apothecon Pharmaceuticals Private Limited?
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