Bi-Coastal Pharma International
FDA inspection history in Shrewsbury, New Jersey, 2022
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One warning letter and one Form 483, at Shrewsbury, New Jersey.
Cited most
Across all Bi-Coastal Pharma International observations on file
- 21 CFR 211.198(a)Complaint files2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(b)Personnel qualifications1
The complete Bi-Coastal Pharma International file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Shrewsbury, New Jersey
One warning letter and one Form 483 · 2022 · 5 observations
Latest: Warning letter, Jun 30, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-30 | Warning letter Warning letter | Shrewsbury, New Jersey | — | $99 |
| 2022-01-14 | 483 Form 483 | Shrewsbury, New Jersey | 5 | $99 |
Investigators on these documents
FEI number 3013263547 · most recent document Jun 30, 2022
About Bi-Coastal Pharma International
How many FDA Form 483s has Bi-Coastal Pharma International received?
FDA Intel has 1 Form 483 on file for Bi-Coastal Pharma International; the most recent is dated Jan 14, 2022.
When was Bi-Coastal Pharma International last inspected by FDA?
The most recent FDA inspection document on file for Bi-Coastal Pharma International is a Form 483 dated Jan 14, 2022, for the site in Shrewsbury, New Jersey.
What did FDA cite at Bi-Coastal Pharma International?
The regulations cited most in the observations on file for Bi-Coastal Pharma International are 21 CFR 211.198(a) (Complaint files), 2 times; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.
Has Bi-Coastal Pharma International received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bi-Coastal Pharma International; the most recent is dated Jun 30, 2022.