R.L. Fine Chem Private Limited
Form 483 issued February 22, 2019 · Bengaluru, India
- Investigator
- Tenzin Jangchup
- Observations
- 4
- Pages
- 3
- FEI number
- 3005560263
In short: On February 22, 2019, FDA issued a Form 483 with 4 observations to R.L. Fine Chem Private Limited in Bengaluru, Karnataka (FEI 3005560263). The investigator was Tenzin Jangchup. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacturing, processing, packing and holding of intermediates and APIs (active pharmaceutical ingredients)…
- 02
Materials and finished goods are not stored in a manner to ensure appropriate monitoring…
- 03
Written records of investigations into failures of a batch to meet specifications or investigations of drug…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Tenzin Jangchup
14 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmR.L. Fine Chem Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at R.L. Fine Chem Private Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected R.L. Fine Chem Private Limited?
Tenzin Jangchup is named on this Form 483. Each investigator has a profile showing what they cite most.
When was R.L. Fine Chem Private Limited inspected by FDA?
This Form 483 is dated February 22, 2019.
How do I get the full Form 483 for R.L. Fine Chem 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.