MEDLEY PHARMACEUTICALS LIMITED
Form 483 issued May 19, 2023 · KACHIGAM, India
- Inspection
- May 15 – May 19, 2023
- Investigator
- Teresa I. Navas
- Observations
- 5
- Pages
- 7
- FEI number
- 3006896204
In short: On May 19, 2023, FDA issued a Form 483 with 5 observations to MEDLEY PHARMACEUTICALS LIMITED in KACHIGAM, DAMAN (FEI 3006896204) after an inspection that ran May 15 – May 19, 2023. The investigator was Teresa I. Navas. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 04
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMEDLEY PHARMACEUTICALS LIMITED history
The site's inspection history, in date order.
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 MEDLEY PHARMACEUTICALS LIMITED?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected MEDLEY PHARMACEUTICALS LIMITED?
Teresa I. Navas is named on this Form 483, for the inspection of May 15 – May 19, 2023. Each investigator has a profile showing what they cite most.
When was MEDLEY PHARMACEUTICALS LIMITED inspected by FDA?
The inspection ran May 15 – May 19, 2023, and the Form 483 is dated May 19, 2023.
How do I get the full Form 483 for MEDLEY PHARMACEUTICALS 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.