Azico Biophore India Private Limited
Form 483 issued December 7, 2015 · Anakapalli, India
- Inspection
- Nov 30 – Dec 7, 2015
- Investigator
- Linda F. Murphy
- Observations
- 7
- Pages
- 6
- FEI number
- 3010823443
In short: On December 7, 2015, FDA issued a Form 483 with 7 observations to Azico Biophore India Private Limited in Anakapalli, Andhra Pradesh (FEI 3010823443) after an inspection that ran Nov 30 – Dec 7, 2015. The investigator was Linda F. Murphy. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (3×) · 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Test procedures are not appropriate to ensure all raw materials, intermediates, and final APIs…
- 02
The Quality Unit did not ensure Out of Specification (OOS) results were fully investigated and conclusions…
- 03
The Quality Unit did not ensure all…
- 04
The Quality Unit approved a change to the batch size of 0 prior to confirmation…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmAzico Biophore India Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Azico Biophore India Private Limited?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Azico Biophore India Private Limited?
Linda F. Murphy is named on this Form 483, for the inspection of Nov 30 – Dec 7, 2015. Each investigator has a profile showing what they cite most.
When was Azico Biophore India Private Limited inspected by FDA?
The inspection ran Nov 30 – Dec 7, 2015, and the Form 483 is dated December 7, 2015.
How do I get the full Form 483 for Azico Biophore India 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.