Galentic Pharma (India) Private Limited
Form 483 issued December 8, 2022 · Gandhidham, India
- Inspection
- Nov 28 – Dec 8, 2022
- Investigators
- Sandra A. Boyd· Ucheabuchi C. Chudi-Nwankwor
- Observations
- 10
- Pages
- 8
- FEI number
- 3012178852
In short: On December 8, 2022, FDA issued a Form 483 with 10 observations to Galentic Pharma (India) Private Limited in Gandhidham, Gujarat (FEI 3012178852) after an inspection that ran Nov 28 – Dec 8, 2022. The investigators were Sandra A. Boyd and Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and laboratory controls account for 6 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The quality control unit lacks authority to review production records to assure that…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
This inspection in context
Sandra A. Boyd
16 documents · 2019–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmGalentic Pharma (India) Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Galentic Pharma (India) Private Limited?
FDA listed 10 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Galentic Pharma (India) Private Limited?
Sandra A. Boyd and Ucheabuchi C. Chudi-Nwankwor are named on this Form 483, for the inspection of Nov 28 – Dec 8, 2022. Each investigator has a profile showing what they cite most.
When was Galentic Pharma (India) Private Limited inspected by FDA?
The inspection ran Nov 28 – Dec 8, 2022, and the Form 483 is dated December 8, 2022.
How do I get the full Form 483 for Galentic Pharma (India) Private Limited?
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