Bi-Coastal Pharma International
Form 483 issued January 14, 2022 · Shrewsbury, New Jersey
- Inspection
- Dec 15, 2021 – Jan 14, 2022
- Investigators
- Guerlain Ulysse· Rose Jean-Mary
- Observations
- 5
- Pages
- 8
- FEI number
- 3013263547
In short: On January 14, 2022, FDA issued a Form 483 with 5 observations to Bi-Coastal Pharma International in Shrewsbury, New Jersey (FEI 3013263547) after an inspection that ran Dec 15, 2021 – Jan 14, 2022. The investigators were Guerlain Ulysse and Rose Jean-Mary. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
4 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is no written testing program designed to assess the stability…
- 03
Complaint records are deficient in that they do not include the findings of the…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBi-Coastal Pharma International history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bi-Coastal Pharma International?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Bi-Coastal Pharma International?
Guerlain Ulysse and Rose Jean-Mary are named on this Form 483, for the inspection of Dec 15, 2021 – Jan 14, 2022. Each investigator has a profile showing what they cite most.
When was Bi-Coastal Pharma International inspected by FDA?
The inspection ran Dec 15, 2021 – Jan 14, 2022, and the Form 483 is dated January 14, 2022.
How do I get the full Form 483 for Bi-Coastal Pharma International?
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