Pharmaceutics International Inc
Form 483 issued March 24, 2017 · Hunt Valley, Maryland
- Inspection
- Mar 13 – Mar 24, 2017
- Investigators
- Chaltu N. Wakijra· Nicholas Violand· Tonia F. Bernard
- Observations
- 4
- Pages
- 4
- FEI number
- 1000513101
In short: On March 24, 2017, FDA issued a Form 483 with 4 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran Mar 13 – Mar 24, 2017. The investigators were Chaltu N. Wakijra, Nicholas Violand and Tonia F. Bernard. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Chaltu N. Wakijra
2 documents · 2016–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmPharmaceutics International Inc history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International Inc?
Chaltu N. Wakijra, Nicholas Violand and Tonia F. Bernard are named on this Form 483, for the inspection of Mar 13 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran Mar 13 – Mar 24, 2017, and the Form 483 is dated March 24, 2017.
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.