BE Pharmaceuticals Private Limited
Form 483 issued June 12, 2014 · Paonta Sahib, India
- Inspection
- Jun 9 – Jun 12, 2014
- Investigator
- Peter E. Baker
- Observations
- 13
- Pages
- 7
- FEI number
- 3009866948
In short: On June 12, 2014, FDA issued a Form 483 with 13 observations to BE Pharmaceuticals Private Limited in Paonta Sahib, Himachal Pradesh (FEI 3009866948) after an inspection that ran Jun 9 – Jun 12, 2014. The investigator was Peter E. Baker. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 8 of 13 observations.
Most cited: 21 CFR 211.160 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 02
Established laboratory control mechanisms…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 04
The number of qualified personnel is inadequate to perform the manufacture…
This inspection in context
Peter E. Baker
11 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmBE Pharmaceuticals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BE Pharmaceuticals Private Limited?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected BE Pharmaceuticals Private Limited?
Peter E. Baker is named on this Form 483, for the inspection of Jun 9 – Jun 12, 2014. Each investigator has a profile showing what they cite most.
When was BE Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jun 9 – Jun 12, 2014, and the Form 483 is dated June 12, 2014.
How do I get the full Form 483 for BE Pharmaceuticals Private Limited?
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.