Pharmaceutics International, Inc.
Form 483 issued April 4, 2016 · Cockeysville, Maryland
- Inspection
- Mar 21 – Apr 4, 2016
- Investigators
- Deyaa Shaheen· Eric L. Dong· Toyin B. Oladimeji
- Observations
- 13
- Pages
- 12
- FEI number
- 3006503102
In short: On April 4, 2016, FDA issued a Form 483 with 13 observations to Pharmaceutics International, Inc. in Cockeysville, Maryland (FEI 3006503102) after an inspection that ran Mar 21 – Apr 4, 2016. The investigators were Deyaa Shaheen, Eric L. Dong and Toyin B. Oladimeji. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 13 observations.
Most cited: 21 CFR 211.113 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written procedures are lacking which describe in sufficient detail the handling of components , drug…
- 03
Production personnel were not practicing good…
- 04
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Deyaa Shaheen
5 documents · 2016–2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmPharmaceutics International, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Pharmaceutics International, Inc.?
Deyaa Shaheen, Eric L. Dong and Toyin B. Oladimeji are named on this Form 483, for the inspection of Mar 21 – Apr 4, 2016. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International, Inc. inspected by FDA?
The inspection ran Mar 21 – Apr 4, 2016, and the Form 483 is dated April 4, 2016.
How do I get the full Form 483 for Pharmaceutics International, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.