PhannScript LLC
FDA inspection history in Somerset, New Jersey, 2016 to 2018
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Somerset, New Jersey.
- 2016The longest 483 on file: 7 observations over 3 pages at Somerset, New Jersey.
Cited most
Across all PhannScript observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete PhannScript 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
Somerset, New Jersey
Two Form 483s · 2016 to 2018 · 11 observations
Latest: Form 483, Aug 7, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-07 | 483 Form 483 | Somerset, New Jersey | 4 | $99 |
| 2016-10-24 | 483 Form 483 | Somerset, New Jersey | 7 | $99 |
Investigators on these documents
Liane Krueger (1)Russell J. Glapion (1)Sena G. Dissmeyer (1)Tonia F. Bernard (1)
FEI number 3012837733 · most recent document Aug 7, 2018
About PhannScript LLC
How many FDA Form 483s has PhannScript LLC received?
FDA Intel has 2 Form 483s on file for PhannScript LLC; the most recent is dated Aug 7, 2018.
When was PhannScript LLC last inspected by FDA?
The most recent FDA inspection document on file for PhannScript LLC is a Form 483 dated Aug 7, 2018, for the site in Somerset, New Jersey.
What did FDA cite at PhannScript LLC?
The regulations cited most in the observations on file for PhannScript LLC are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.