FDA WARNING_LETTER - P.A. Benjamin Manufacturing Co., Ltd. - May 11, 2012

The FDA issued a Warning Letter to P.A. Benjamin Manufacturing Co., Ltd. following a May 5-11, 2012, inspection of their pharmaceutical manufacturing facility in Kingston, Jamaica. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), causing their drug products to be adulterated. The firm's May 24, 2012, response was deemed inadequate.

CGMP violations included failure to thoroughly investigate batch failures, an inadequate quality control unit, failure to conduct specific identity tests on components, lack of written procedures to prevent microbial contamination in non-sterile drug products, inadequate equipment cleaning and maintenance procedures, and failure to establish and validate production and process controls.

Additionally, several OTC products (Benjamins Flu Relief, Diphenhydramine Expectorant, Diphenhydramine Elixir, Sinus, Cold and Cough, and Infants Gripe Mixture) were identified as unapproved new drugs under Section 505(a) of the Act and misbranded under Sections 502(f)(2) and 502(c). Misbranding issues included non-compliant dosing directions, active ingredients, indications, lack of required warnings (e.g., liver warning for acetaminophen), and failure to meet "Drug Facts" labeling requirements.

The FDA questioned the effectiveness of the firm's quality system and recommended a comprehensive assessment and hiring a qualified consultant. The company must provide a written response within fifteen working days detailing corrective actions, supporting documentation, and timelines. Failure to correct these violations may lead to FDA withholding approval of new applications and refusing admission of the firm's products into the U.S.