December 483s: Most Popular and Newsworthy

In December, one form 483 was posted, issued to Sun Pharmaceuticals in Halol, India. The 483 is 16 pages long and includes 8 observations, including detailed issues with the micro laboratory. We cover form 483 below.

[Related: Check out Redica’s extensive database of 483s. Get your free personalized 483 Observation Report.]

483s Posted

DRUG FIRM | Sun Pharmaceuticals

Sun Pharmaceuticals site in Halol, India received a 16-page, 8 observation form 483 at the close of inspection on December 13, 2019. Three investigators conducted the inspection. Observation #4 is noted as a repeat from a previous inspection. I would not be surprised to see a warning letter follow from this inspection based on the topics covered and that it identifies very detailed problems associated with aseptic processing and the micro laboratory.

Observations include but are not limited to:

• The Quality Unit does not implement adequate and validated controls to ensure that products meet the quality they are purported to. While this observation, #1 in the list, is fairly well redacted it appears to concern a collection of OOS events where the root cause was not identified.
• The Quality Unit failed to implement controls over computer systems that would prevent environmental monitoring data in the QC laboratory from being manipulated. This includes EM data associated with the manufacture of sterile products. The observation provides four pages of detail. Any firm using a similar system to the MODA-EM system would be well advised to read through this.
• The firm apparently didn’t follow its own procedure in testing for quality attributes. While the observation is well redacted, it seems that fewer vials were included in the evaluation than should have been.
• Swab samples of equipment in the sterile area are not adequately described in the procedure. Thus it is unclear what is and isn’t sampled based on the procedure.
• Aseptic processing areas are not subject to adequate environmental monitoring. This observation describes shortcomings in the online particle count sampling location risk assessment.
• Visual inspection of filled drug product vials is inadequate.
• The Quality Unit did not respond effectively to a large number of critical equipment alarms.

Compounding/Outsourcing Facilities

Anazaohealth Corporation

Anazaohealth Corporation (Las Vegas, NV) received a form 483 at the close of inspection on September 19, 2019.

M Drug, LLC, dba Northern Light Pharmacy

M Drug, LLC, dba Northern Light Pharmacy (Bangor, ME) received an amended form 483 issued at the close of inspection on August 20, 2019.

Mandell’s Clinical Pharmacy

Mandell’s Clinical Pharmacy (Somerset, NJ) received a form 483 at the close of inspection on July 25, 2019.

Nubratori Inc dba Nubratori Rx

Nubratori Inc dba Nubratori Rx (Torrance, CA) received a form 483 based on an inspection ending September 26, 2019.

SBH Medical LTD

SBH Medical LTD (Worthington, OH) received a form 483 at the close of inspection on September 30, 2019.

[Related: Check out Redica’s extensive database of 483s. Get your free personalized 483 Observation Report.]