Pharmaceutics International Inc
Form 483 issued March 10, 2016 · Hunt Valley, Maryland
- Inspection
- Feb 22 – Mar 10, 2016
- Investigators
- Jonathan W. Chapman· Zhongren Wu
- Observations
- 7
- Pages
- 19
- FEI number
- 1000513101
In short: On March 10, 2016, FDA issued a Form 483 with 7 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran Feb 22 – Mar 10, 2016. The investigators were Jonathan W. Chapman and Zhongren Wu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 6 of 7 observations.
Most cited: 21 CFR 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
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International Inc?
Jonathan W. Chapman and Zhongren Wu are named on this Form 483, for the inspection of Feb 22 – Mar 10, 2016. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran Feb 22 – Mar 10, 2016, and the Form 483 is dated March 10, 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.